[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"breast-cancer-female\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:breast-cancer-female":31},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,79,0,25,[9,50,76,106,136,164,190,219,247,279,306,331,359,378,401,426,455,479,500,545,569,592,618,644,670],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":33,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100524209","biennial-cem-in-women-with-a-personal-history-of-breast-cancer-100524209",false,"NCT06105749","Biennial CEM in Women With a Personal History of Breast Cancer","Outcome of Biennial Screening Contrast-Enhanced Mammography (CEM) in Women With a Personal History of Breast Cancer (PHBC)","Inclusion Criteria:\n\n* Asymptomatic women, ages 30-79, with a personal history of breast cancer who are at least one year out from any breast cancer surgery and\u002For treatment and are scheduled to have a routine annual mammogram with tomosynthesis (DBT).\n\nExclusion Criteria:\n\n* Women with a history of prior moderate or severe iodinated contrast reaction \\[only those with a prior mild reaction that can be managed by pre-medication AND with and a strong desire to participate will be allowed to participate. However, among these women with a mild sensitivity, if they are allergic to Benadryl (one of the premedications), they will be excluded\\].\n* Women with implant(s) in the breasts to be screened (as this creates artifacts and diagnostic performance of imaging in women with implants likely does not generalize to those without implants, and the sample size with implants would be too small to infer conclusions.\n* Women who have had bilateral mastectomy\n* Women with a history of kidney failure or estimated glomerular filtration rate (eGFR) \\\u003C 30 mL\u002Fmin\n* Pregnancy or lactation\n* Women actively being treated for cancer of any type with chemotherapy.\n* Women with stage 4 metastasis to visceral areas or brain\n* Women with known personal history of breast cancer who have a screening breast MRI exam within 24 months prior to the current round of CEM.\n* Women with known personal history of breast cancer who had a CEM exam within the prior 23 months",true,"FEMALE","30 Years","79 Years",{"count":22,"type":23},1600,"ESTIMATED","INTERVENTIONAL",[26],"NA","This is a prospective clinical trial that will examine if biennial contrast-enhanced mammography added to annual 3D mammography (tomosynthesis) substantially improves breast cancer detection with minimal increase in false-positives, in women with a personal history of breast cancer.",[29,30,31,32],"Breast Cancer","Breast Neoplasms","Breast Cancer Female","Neoplasms",[34,35,36],"Breast cancer screening","Digital Breast Tomosynthesis","Contrast-Enhanced Mammogram","RECRUITING","2026-08-17",{"date":40,"type":41},"2026-08-19","ACTUAL",{"date":43,"type":41},"2023-11-08",{"date":45,"type":23},"2031-04",{"name":47,"class":48},"Wendie Berg","OTHER",6,{"id":51,"slug":52,"hasResults":12,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":58,"enrollmentInfo":59,"targetDuration":61,"studyType":62,"phases":4,"briefSummary":63,"conditions":64,"keywords":65,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":67,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":75},"100400516","a-study-to-identify-breast-cancer-idbc-100400516","NCT04495244","A Study to Identify Breast Cancer (IDBC)","Investigation of a Novel Blood Test to Identify Breast Cancer (IDBC)","IDBC","Inclusion criteria\n\n* Aged 30-75 years\n* Normal breast examination - No cancer detected\u002Fsuspected by physical exam, diagnostic radiology or screening mammography\n* Women with suspected Invasive Breast Cancer\n* Individuals with an abnormal or suspicious mammogram\n* Abnormal screening mammogram with suspected benign breast disease or proliferative changes\n\nExclusion criteria\n\n* Cancer diagnosis\n* Male\n* Breast surgery within the previous 12 months (for any reason) or recent breast biopsy (including needle core biopsy)\n* Previous history of any cancer\n* Concomitant or other concurrent anti-cancer therapy\n* Inoperable or inflammatory breast cancer","75 Years",{"count":60,"type":23},10000,"3 Years","OBSERVATIONAL","Detecting cancer as early as possible is key to achieving positive outcomes in response to diagnosis and treatment. The current project is aimed at validating a novel blood-based breast cancer identification test (Syantra DX Breast Cancer) that has been developed by Syantra Inc. Syantra DX Breast Cancer measures gene expression signatures in whole blood, and has been retrospectively demonstrated in 780 samples. The test uses proprietary algorithms to analyse gene expression characteristics from a novel multi-biomarker panel, and then classify a sample as positive or negative for breast cancer. Based upon test performance in a retrospective environment, a prospective validation study is being proposed.\n\nThe primary objective of this study is to validate Syantra DX Breast Cancer methodology and biomarker panel using prospective samples, well categorized by diagnostic imaging scores, pathology outcomes, and subject characteristics.",[31],[66],"Detection, blood test, clinical assay",{"date":40,"type":41},{"date":69,"type":41},"2019-01-24",{"date":71,"type":23},"2032-12-31",{"name":73,"class":74},"Syantra Inc.","INDUSTRY",4,{"id":77,"slug":78,"hasResults":12,"nctId":79,"briefTitle":80,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":12,"sex":18,"minAge":83,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":24,"phases":86,"briefSummary":88,"conditions":89,"keywords":92,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":105},"100444813","phase-3-long-term-outcomes-of-lidocaine-infusions-for-post-operative-pain-lolipop-trial-100444813","NCT05072314","Long-term Outcomes of Lidocaine Infusions for Post-Operative Pain (LOLIPOP) Trial","LOLIPOP","Inclusion Criteria:\n\n* Consenting adult female patients (≥18 years) undergoing mastectomy (unilateral or bilateral) or breast conserving surgery (unilateral or bilateral) for the primary excision of confirmed or suspected primary breast cancer under general anaesthesia (including those with simultaneous insertion of tissue expanders or implants)\\*. \\* this specifically excludes patients undergoing surgery for locoregional recurrence\n* American Society of Anaesthesiologist (ASA) physical scale 1-3\n\nExclusion Criteria:\n\n* Mastectomy or breast conserving surgery with add on procedures e.g laparoscopic salpingectomy\n* Where surgery is being performed for locoregional recurrence of breast cancer\n* Pre-existing pain at site of surgery, axilla, ipsilateral side of chest wall or the ipsilateral upper arm (at diagnosis prior to any tumor locating procedures)\n* Re-excision procedures where the margins at the index surgery have been deemed insufficient\n* When immediate autologous reconstruction surgery is planned\n* Where delayed autologous reconstruction surgery on the operative breast within one year is planned\n* Planned use of regional analgesia infusions\n* Impaired cognition\n* Pregnant or lactating females\n* Transgender patients\n* Known metastatic disease\n* History of anaphylaxis, sensitivity or known contraindication to lidocaine (or other amide local anaesthetic agents e.g. other amide local anaesthetic agents: ropivacaine, bupivacaine, mepivacaine, prilocaine, etidocaine), including patients with porphyria or methaemoglobinaemia\n* History of epilepsy\n* Baseline heart rate \\< 50 bpm or systolic blood pressure \\< 100mmHg.\n* Acute coronary event in the last three months\n* Cardiac conduction abnormalities, including; Atrial fibrillation, Heart block (all degrees), Bundle Branch Block or Fascicular block, Prolonged QT interval, Wolf Parkinson White syndrome, channelopathy such as Brugada syndrome. A preoperative Electrocardiogram (ECG) is not mandatory, unless clinically indicated\n* Abnormal serum potassium concentration (based upon site laboratory reference ranges)\n* Active liver disease e.g. viral hepatitis, alcoholic liver disease, non-alcoholic fatty liver disease, haemochromatosis, other rarer causes)\n* Medications within the last 7 days which are known \u002F suspected to slow lidocaine metabolism (amiodarone, beta blockers, cimetidine, fluoroquinolones, fluvoxamine, imidazoles, macrolides, verapamil, HIV drugs)\n* Cardiac Failure (any documented heart failure at peroperative assessment or GP records)\n* Severe Renal Failure (Creatinine Clearance of less than 30ml\u002Fmin or dialysis dependent)\n* Co-administration of lidocaine within 24 hours prior to surgery for other reasons (e.g. lidocaine patches","18 Years",{"count":85,"type":23},4300,[87],"PHASE3","The LOLIPOP Trial is a large (n=4,300 patients) pragmatic, international, multicentre, prospective, randomised, double blind, placebo-controlled, parallel assessment, safety and effectiveness superiority study.",[29,31,90,91],"Breast Conserving Surgery","Mastectomy",[93,94,95],"Anaesthesia","Local Anaesthesia","Chronic Post Surgical Pain","2026-08-10",{"date":98,"type":41},"2026-08-12",{"date":100,"type":41},"2022-07-27",{"date":102,"type":23},"2029-05",{"name":104,"class":48},"Monash University",49,{"id":107,"slug":108,"hasResults":12,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":12,"sex":113,"minAge":83,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":24,"phases":116,"briefSummary":118,"conditions":119,"keywords":124,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":135},"100549871","phase-2-the-sappho-study-sequential-therapy-with-curative-intent-in-de-novo-her2-metastatic-breast-cancer-100549871","NCT06439693","The SAPPHO Study: Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer","A Single-Arm, Phase II Study of Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer: The SAPPHO Study","Inclusion criteria:\n\n* Participants must have histologically or cytologically confirmed unresectable locally advanced or metastatic invasive breast carcinoma. Patients must have stage IV breast carcinoma at diagnosis (i.e., de novo metastatic) with unequivocal evidence of metastasis on imaging.\n* Diagnosis of HER2-positive invasive breast carcinoma and 3+ by immunohistochemistry on both breast and metastatic biopsies, as defined by the current American Society of Clinical Oncology - College of American Pathologists (ASCO\u002FCAP) guidelines. HER2 status must be determined at a Clinical Laboratory Improvements Amendments (CLIA)-certified or International Organization for Standardization (ISO)-accredited laboratory (central testing not required). Patients with HER2 1+ or 2+ disease which is HER2 FISH positive are not eligible to enroll.\n* No prior systemic therapy for invasive breast cancer, aside from first-line trastuzumab\u002Fpertuzumab\u002Ftaxane (THP) within 6 weeks from treatment start. Prior endocrine therapy for non-invasive breast carcinoma or non-cancerous lesions is allowed if it has been completed at least 5 years prior to study entry.\n* Age ≥18 years. Because no dosing or adverse event data are currently available on the use of trastuzumab, pertuzumab, paclitaxel, trastuzumab deruxtecan, T-DM1 and tucatinib in Participants \\<18 years of age, children are excluded from this study, but will be eligible for future pediatric trials.\n* Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1\n* Left ventricular ejection fraction (LVEF) ≥50%, as assessed by echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA) documented within 12 weeks prior to first dose of study treatment, or within 12 weeks before starting THP for patients who start metastatic therapy prior to study entry.\n* Participants must meet the following organ and marrow function as defined below within 28 days prior to registration:\n\n  * Hgb ≥9.0 g\u002FdL\n  * Absolute Neutrophil Count ≥ 1,000 \u002Fmm3\n  * Platelets ≥100,000\u002Fmm3\n  * Total bilirubin ≤ 1.5 x ULN (institutional) or direct bilirubin within normal limits in patients with a history of Gilbert\\'s syndrome.\n  * AST and ALT ≤ 2.5 x ULN (institutional) or ≤ 5 x ULN for participants with documented liver metastases\n  * Serum creatinine ≤ 1.5 x ULN (institutional) OR calculated GFR ≥60mL\u002Fmin\n* Participants with concurrent human immunodeficiency virus (HIV) infection are eligible provided the following criteria are met:\n\n  * CD4+ T-cell (CD4+) counts \\> 350 cells\u002FuL\n  * No history of AIDS-defining opportunistic infection within 12 months prior to enrollments\n  * Any medication used in an ART regimen must have no known interaction with the agents used in the study treatment regimen.\n* Participants with active or chronic Hepatitis B or C are eligible provided they meet the liver function criteria described in 3.1.7 and are not on a medication with a known liver function criteria described in 3.1.7 and are not on a medication with a known interaction with the agents used in the study treatment regimen. The following guidance applies:\n\n  * patients with chronic HBV infection with active disease who meet the FDA criteria for anti-HBV therapy should be on a suppressive antiviral therapy prior to initiation of cancer therapy.\n  * patients with a history of HCV infection should have completed curative antiviral treatment. HCV viral load must be below the limit of quantification.\n  * patients who are HCV Ab positive but HCV RNA negative due to prior treatment or natural resolution are eligible.\n* Participants with brain metastases identified at diagnosis or at time of screening are eligible if the following criteria are met:\n\n  * Known, untreated brain metastases must undergo definitive local therapy - as determined by treating physician - prior to study entry.\n  * Treated brain metastases must be clinically stable since treatment. Restaging brain MRI is not required to deem eligibility if local therapy was given within 28 days from first dose of study treatment. Patients are eligible if time from local therapy and first dose of study treatment is:\n\n    * 7 days for stereotactic radiosurgery (SRS);\n    * 14 days for whole-brain radiation therapy (WBRT);\n    * 28 days for surgical resection.\n  * Patients who have already started THP prior to study entry and have brain metastasis detected at screening MRI are eligible after completion of definitive local therapy- as determined by treating physician. Systemic treatment can be interrupted as determined by the treating physician and after discussion with the Sponsor Investigator.\n* Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible (i.e., adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer).\n* This study involves agents that have known genotoxic, mutagenic and teratogenic effects. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her Partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 7 months after completion of study therapy.\n* Women of childbearing potential must have had a negative pregnancy test within 14 days of registration. Childbearing potential is defined as: those who have not been surgically sterilized and\u002For have had a menstrual period in the past 12 months or who have been on ovarian suppression in the past year.\n* Ability to understand and the willingness to sign a written informed consent document indicating awareness of the investigational nature and the risks of this study\n* Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.\n\nExclusion criteria:\n\n* Prior history of invasive breast carcinoma\n* Treatment with any other investigational agents for this condition.\n* Major surgical procedure (excluding placement of vascular access) or significant traumatic injury within 28 days of study entry or an anticipated need for major surgery during the study.\n* Extracranial palliative radiotherapy within 7 days prior to enrollment.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to trastuzumab, pertuzumab, paclitaxel, trastuzumab deruxtecan, trastuzumab emtansine, tucatinib.\n* Participants with a medical history of myocardial infarction within 6 months before enrollment or symptomatic CHF (NYHA Class II to IV).\n* Subjects must not have any of the following:\n\n  * Any untreated brain lesion on screening MRI, unless approved by the Sponsor Investigator\n  * Ongoing use of systemic corticosteroids for control of symptoms of brain metastases at a total daily dose of \\>2 mg of dexamethasone (or equivalent).\n  * Known or concurrent leptomeningeal disease on screening MRI\n  * Poorly controlled (\\>1\u002Fweek) generalized or complex partial seizures\n* History of arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia), which is symptomatic or requires treatment (CTCAE Grade 3), symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Participants with atrial fibrillation controlled by medication or arrhythmias controlled by pacemakers may be permitted upon discussion with the Sponsor-Investigator.\n* History of (non-infectious) ILD\u002Fpneumonitis that required steroids, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening.\n* History of other lung disease, such as:\n\n  * Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (e.g., pulmonary emboli within 3 months of study enrolment, severe asthma, severe chronic obstructive pulmonary disorder (COPD), restrictive lung disease, pleural effusion etc.).\n  * Any autoimmune, connective tissue or inflammatory disorders (e.g., rheumatoid arthritis, Sjogren's, sarcoidosis, etc.) where there is documented, or a suspicion of pulmonary involvement at the time of screening.\n  * Prior pneumonectomy.\n* Active or uncontrolled clinically serious infection\n* Have inability to swallow pills or significant gastrointestinal disease which would preclude the adequate oral absorption of medications\n* Have ongoing ≥ Grade 2 diarrhea of any etiology\n* Participants receiving any medications or substances that are inhibitors or inducers of CYP2C8 and\u002For CYP3A4 are ineligible. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently updated medical reference.\n* Pregnant women are excluded from this study because of potential for teratogenic or abortifacient effects of study drugs. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with study drugs, breastfeeding should be discontinued prior to enrollment.","ALL",{"count":115,"type":23},72,[117],"PHASE2","The purpose of this study is to test the safety and effectiveness of a sequence of drugs (a Taxane plus Trastuzumab plus Pertuzumab followed by Trastuzumab Deruxtecan, followed by Tucatinib plus Ado-Trastuzumab Emtansine (T-DM1), followed by Trastuzumab plus Pertuzumab plus Tucatinib) in HER2+ Breast Cancer. The study will help investigators understand whether first intensifying therapy for a specific period and then stopping treatment is safe and effective for participants.\n\nThe names of the study drugs involved in this study are:\n\n* Paclitaxel (a type of anti-microtubule agent)\n* Docetaxel (a type of anti-microtubule agent)\n* Nab-Paclitaxel (a type of anti-microtubule agent)\n* Trastuzumab (a type of IgG1 kappa monoclonal antibody)\n* Pertuzumab (a type of monoclonal antibody)\n* Trastuzumab Deruxtecan (a type of HER2-directed antibody drug conjugate)\n* Tucatinib (Tyrosine Kinase HER2 Inhibitor)\n* Ado-trastuzumab emtansine or T-DM1 (a type of HER2-targeted antibody-drug conjugate)",[31,29,120,121,122,123],"Breast Cancer Metastatic","Estrogen Receptor-positive Breast Cancer","HER2-positive Breast Cancer","Stage IV Breast Cancer",[29,31,120,125,122,123],"Estrogen Receptor-Positive Breast Cancer","2026-08-04",{"date":128,"type":41},"2026-08-06",{"date":130,"type":41},"2024-08-08",{"date":132,"type":23},"2033-03-30",{"name":134,"class":48},"Dana-Farber Cancer Institute",1,{"id":137,"slug":138,"hasResults":12,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":4,"eligibilityCriteria":142,"healthyVolunteers":12,"sex":113,"minAge":83,"maxAge":4,"enrollmentInfo":143,"targetDuration":4,"studyType":24,"phases":145,"briefSummary":146,"conditions":147,"keywords":153,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":156,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":163},"100529629","phase-2-dato-base-datopotamab-deruxtecan-for-breast-cancer-brain-metastases-100529629","NCT06176261","DATO-BASE: DATOpotamab-deruxtecan for Breast Cancer Brain metAstaSEs","DATO-BASE: A Phase 2 Trial of DATOpotamab-deruxtecan for Breast Cancer Brain metAstaSEs","Inclusion Criteria :\n\n* Metastatic breast cancer that is pathologically confirmed to be HER2-negative according to 2018 ASCO\u002FCAP guidelines 55.\n* Radiological confirmation of metastatic disease.\n* Cohorts A and B: Presence of newly diagnosed brain metastases or brain metastases progressing after prior local and\u002For systemic therapy.\n* Cohorts A and B: Participants must have a baseline MRI of the brain performed with and without gadolinium contrast, and must have central nervous system metastases with at least one measurable brain metastasis ≥ 1.0 cm in size (per RANO-BM) that has not been irradiated, or has progressed despite prior radiation therapy and\u002For systemic therapy (in the opinion of the treating physician). For cohorts A and B, head CT with contrast may be used in place of MRI at baseline and throughout the trial if MRI is contraindicated and the participant's CNS metastases are clearly measurable by head CT.\n* Cohorts C: Radiological evidence of evaluable leptomeningeal disease and clinical diagnosis of LMD per treating investigator. A positive CSF cytology is not required.\n* Cohort A: prior progression to treatment with at least one line of endocrine treatment (with or without CDK4\u002F6 inhibition) in the metastatic setting is mandatory. Patients experiencing recurrence during adjuvant endocrine treatment will be also considered eligible for the trial. There is no limit on the number of prior lines acceptable for the purpose of enrollment in this study.\n* Cohort B and C: no prior treatment is required (i.e., previously untreated patients are eligible). There is no limit on the number of prior lines of therapy acceptable for the purpose of enrollment in this study.\n* Participants may have measurable or non-measurable extracranial disease. Participants are NOT required to have extracranial disease, but must have imaging done to document disease status at baseline.\n* Age ≥ 18 years.\n* ECOG Performance Status 0-2\n* Participants must have adequate treatment washout period before registration, defined as \\> 4 weeks from major surgery, \\> 2 weeks from radiation treatment. For weekly chemotherapy regimens, \\> 2 weeks from chemotherapy; for every 3 weekly regimens, \\> 3 weeks from chemotherapy. At least 2 weeks from other systemic or targeted or investigational therapies (other than endocrine therapy) for breast cancer. No washout is required for endocrine therapy (e.g. aromatase inhibitors, tamoxifen, fulvestrant) but patients should discontinue prior to start of protocol therapy. Patients on ovarian suppression are allowed (but not required) to continue ovarian suppression at the discretion of their treating provider.\n* Left ventricular ejection fraction (LVEF) ≥ 50% by echocardiogram (ECHO) or multigated acquisition (MUGA) scan.\n* Adequate organ function as defined by the following values:\n\n  * Hemoglobin ≥ 9.0 g\u002FdL. Red blood cell\u002Fplasma transfusion is not permitted within 1 week prior to screening assessment.\n  * Absolute neutrophil count ≥1,500\u002Fmm3. Granulocyte colony-stimulating factor administration is not permitted within 1 week prior to screening assessment.\n  * Platelets ≥100,000\u002Fmm3. Platelet transfusion is not permitted within 1 week prior to screening assessment.\n  * Total bilirubin ≤ 1.5 institutional ULN if no liver metastases; or ≤ 3 x ULN in the presence of documented Gilbert's syndrome (unconjugated hyperbilirubinemia) or liver metastases at baseline.\n  * AST(SGOT)\u002FALT(SGPT) ≤ 2.5 × institutional ULN OR ≤ 5.0 x institutional ULN for patients with documented liver metastases\n  * Serum creatinine ≤ 1.5 mg\u002FdL (or glomerular filtration rate ≥ 30 ml\u002Fmin as determined by the Cockcroft-Gault equation)\n* Participants with a history of chronic viral conditions such as HIV, Hepatitis B\u002FC, should not be systemically excluded but have thoughtful consideration of inclusion, unless safety is a concern. Testing for these conditions is not required at baseline.\n* Female subjects of childbearing potential must have a negative serum or urine pregnancy test within 14 days of initiating protocol therapy.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Visceral crisis or impending visceral crisis\n* CNS complications for whom urgent neurosurgical intervention is indicated (i.e., resection, shunt placement)\n* Indication for immediate local therapy to CNS lesion(s) as defined by local standard\n* Evidence of significant (i.e., symptomatic) intracranial hemorrhage\n\n  -\\> 2 seizures within 4 weeks prior to study entry (registration)\n* Ongoing\u002Fpersistent toxicities caused by previous anti-cancer therapy (except alopecia) not yet improved to Grade ≤ 1 OR baseline prior to study entry (registration)\n* Known contraindication to MRI (e.g., due to pacemaker, ferromagnetic implants, claustrophobia, extreme obesity, hypersensitivity). However, for cohorts A and B, head CT with contrast may be used in place of MRI at baseline and throughout the trial if MRI is contraindicated and the participant's CNS metastases are clearly measurable by head CT.\n* Concurrent administration of other anti-cancer therapy during the course of this study is not allowed. Concurrent use of supportive care medications is allowed, and certain medications are required (see Section 5.1).\n* Uncontrolled intercurrent illness, including (but not limited to) active infection, severely compromised pulmonary function, unstable angina pectoris, uncontrolled cardiac arrhythmia, active ischemic heart disease, myocardial infarction within the previous six months, gastric or duodenal ulceration diagnosed within the previous six months, chronic liver or renal disease, or severe malnutrition. Note that if a patient has controlled diabetes mellitus, but is unable to monitor blood glucose at home, they will be excluded from the trial.\n* Participants must not have a condition requiring ongoing systemic treatment with corticosteroids (\\>4 mg daily dexamethasone (or bioequivalent)) or other immunosuppressive medications within 7 days prior to the baseline MRI. Corticosteroids administration must be stable and planned to remain ≤ 4 mg daily for the duration of protocol treatment. However, use of corticosteroids for clinical symptoms is allowed based upon treating physician discretion.\n* History of non-infectious interstitial lung disease (ILD)\u002Fpneumonitis that required steroids, current ILD\u002Fpneumonitis, or suspected ILD\u002Fpneumonitis that cannot be ruled out by imaging at screening.\n* A history of uncontrolled seizures, CNS disorders, or psychiatric disability judged by the investigator to be clinically significant and adversely affecting compliance to study drugs.\n* A history of malignancy other than breast cancer, except (a) adequately resected non-melanoma skin cancer, (b) curatively treated in situ disease, or (c) other solid tumors curatively treated, with no evidence of disease for ≥ 3 years.\n* Major surgery, open biopsy, or significant traumatic injury within 28 days prior to the initiation of protocol therapy, or anticipation of need for a major surgical procedure during the study.\n* Clinically significant corneal disease.\n* Has a history of severe hypersensitivity reactions to either the drug or inactive ingredients (including but not limited to polysorbate 80) of datopotamab deruxtecan.\n* History of severe hypersensitivity reactions to other monoclonal antibodies\n* Negative pregnancy test (urine and\u002For serum) is required for women of childbearing potential. Pregnant or lactating women are excluded from participation due to potential teratogenic effects of study drug.\n* Female participants must be either:\n\n  * post-menopausal for at least 1 year\n  * surgically sterile, or\n  * if of childbearing potential and sexually active with a non-sterilized male partner, must agree to use one highly effective form of birth control for the entire treatment period and for at least 7 months after the last dose of datopotamab deruxtecan (see Section 5.4 for complete list of highly effective birth control methods).\n* Female participants must not donate, or retrieve for their own use, ova at any time during this study and for at least 7 months after the last dose of datopotamab deruxtecan.\n* Female participants must refrain from breastfeeding while on study and for at least 7 months after the last dose of datopotamab deruxtecan.\n* Male participants who intend to be sexually active with a female partner of childbearing potential must be surgically sterile or using an acceptable method of contraception (see Section 5.4 for complete list of highly effective birth control methods) from the time of screening throughout the total duration of the study and the drug washout period (at least 4 months after the last dose of study intervention) to prevent pregnancy in a partner. Male participants must not donate or bank sperm during this same time period.",{"count":144,"type":23},58,[117],"The purpose of this study is to test the safety and effectiveness of the study drug datopotamab deruxtecan in participants with metastatic breast cancer that has spread to the brain.\n\nThe name of the study drug used in this research study is:\n\nDatopotamab deruxtecan (a type of antibody-drug conjugate)",[29,31,148,149,150,151,152],"Metastatic Triple-Negative Breast Carcinoma","ER Positive Breast Cancer","HER2-negative Breast Cancer","HER2 Negative Breast Carcinoma","ER-negative Breast Cancer",[29,31,148,149,154,151,155],"HER2 Negative Breast Cancer","ER Negative Breast Cancer",{"date":128,"type":41},{"date":158,"type":41},"2024-01-08",{"date":160,"type":23},"2029-01-01",{"name":162,"class":48},"Nancy Lin, MD",3,{"id":165,"slug":166,"hasResults":12,"nctId":167,"briefTitle":168,"officialTitle":168,"acronym":169,"eligibilityCriteria":170,"healthyVolunteers":12,"sex":18,"minAge":83,"maxAge":4,"enrollmentInfo":171,"targetDuration":4,"studyType":24,"phases":173,"briefSummary":174,"conditions":175,"keywords":176,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":135},"100558513","guided-digital-self-hypnosis-solution-for-managing-hot-flashes-in-patients-undergoing-adjuvant-hormone-therapy-100558513","NCT06552091","Guided Digital Self-Hypnosis Solution for Managing Hot Flashes in Patients Undergoing Adjuvant Hormone Therapy","HYBOU","Inclusion Criteria:\n\n* Adult patient,\n* WHO ≤ 2,\n* Patient who is premenopausal, perimenopausal, or postmenopausal at diagnosis,\n* Patient being treated for non-metastatic breast cancer,\n* Ongoing adjuvant endocrine therapy, with or without concomitant anti-CDK 4\u002F6 targeted therapy,\n* Patient reporting at least 50 hot flashes per week or at least 7 hot flashes per day\n* Patient has a computer device capable of accessing the self-hypnosis program link,\n* Information provided and informed consent signed,\n* Patient affiliated with the social security system.\n\nExclusion Criteria:\n\n* Male,\n* Patient with hearing impairments,\n* Patient with psychotic and\u002For cognitive disorders As assessed by the clinician,\n* Patient who does not understand the French language,\n* Patient not diagnosed with non-metastatic breast cancer,\n* Patient not undergoing anti-aromatase treatment,\n* Patient reporting fewer than 50 hot flashes per week or fewer than 7 hot flashes per day,\n* Prior participation in a hypnosis or self-hypnosis program before inclusion,\n* Patient participating in a therapeutic program related to hot flashes,\n* Patient already included in another therapeutic trial on the same topic,\n* Patient already included in another therapeutic trial with an experimental drug,\n* Pregnant or breastfeeding woman,\n* Patient deprived of liberty (including guardianship and curatorship).",{"count":172,"type":23},76,[26],"Patients treated for breast cancer with hormone therapy (HT) suffer from hot flashes. This side effect impacts treatment adherence. Indeed, approximately 50% of women take less than 80% of the prescribed dose, and up to 50% abandon their treatment before the fifth year of prescription, significantly increasing the risk of recurrence. Moreover, these hot flashes strongly impact the quality of life. According to the CANTO study, these hot flashes can persist up to two years after diagnosis, affecting social relationships, return to work, and physical and mental health.\n\nSome side effects resulting from HT (sleep disturbances, fatigue, hot flashes) could be alleviated by a non-pharmacological approach involving the patient.\n\nOur hypothesis is that a non-pharmacological solution, such as the use of self-hypnosis, could reduce hot flashes and the side effects related to HT or the perception thereof in patients treated for breast cancer. Consequently, this could improve the quality of life and lead to better treatment adherence.\n\nThe principal objective is to evaluate the effect of daily guided self-hypnosis sessions in reducing hot flashes in patients with non-metastatic breast cancer receiving anti-aromatase hormone therapy.\n\nThe secondary objectives are to evaluate :\n\n* Patient adherence to guided self-hypnosis via a digital solution\n* Quality of life\n* Sleep quality\n* Satisfaction with care\n* Usability of the digital tool\n\nThe originality of this clinical trial is the proposal of self-hypnosis sessions over three weeks with three different themes using a digital solution.",[31],[177,178,179,180,181],"breast cancer","non-metastatic","hormone therapy","hot flashes","self-hypnosis","2026-08-03",{"date":126,"type":41},{"date":185,"type":41},"2024-10-17",{"date":187,"type":23},"2028-02-17",{"name":189,"class":48},"Institut de Cancérologie de Lorraine",{"id":191,"slug":192,"hasResults":12,"nctId":193,"briefTitle":194,"officialTitle":195,"acronym":196,"eligibilityCriteria":197,"healthyVolunteers":12,"sex":18,"minAge":198,"maxAge":4,"enrollmentInfo":199,"targetDuration":4,"studyType":24,"phases":201,"briefSummary":202,"conditions":203,"keywords":207,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":75},"100480377","telehealth-resistance-exercise-intervention-to-preserve-dose-intensity-and-vitality-in-elder-breast-cancer-patients-100480377","NCT05535192","TeleHealth Resistance Exercise Intervention to Preserve Dose Intensity and Vitality in Elder Breast Cancer Patients","TeleHealth Resistance Exercise Intervention to Preserve Dose Intensity and Vitality in Elder Breast Cancer Patients (THRIVE-65)","THRIVE-65","Inclusion Criteria:\n\n* Women age \\>=65\n* Diagnosed with stage I-III invasive breast cancer\n* BMI between 18-50 kg\u002Fm2\n* Scheduled to begin at least 10 weeks of neoadjuvant or adjuvant cytotoxic chemotherapy for curative intent\n* If enrolled in clinical chemotherapy drug trial, considered eligible if regimen includes an anthracycline or a taxane, unless the trial alters the chemotherapy agents\u002Fdoses according to patient response (e.g.; I-SPY trials)\n* Self-reported ability to walk for 6 minutes and\u002For 2 blocks (with or without assistive device)\n* Ability to provide written informed consent.\n* Ability to understand, speak, and read English. This is because many of the study instruments used are not readily available in multiple languages. Additionally, site-based study staff, such as exercise physiologists, are not bilingual and not all sites have access to interpreters.\n\nExclusion Criteria:\n\n* Following a therapeutic diet for co-morbid disease where the THRIVE-65 diet would be contraindicated as assessed by the RD\n* Engaging in 2 or more sessions of strength training exercise per week over a period of at least 3 consecutive months over the past year\n* Engaging in aerobic activity at a level that includes competitive events (e.g., marathon, triathlon, running races) over the past year\n* Presence of medical conditions or medications that would prohibit participation in an exercise program\n* Current use of weight-loss medication\n* Documented history of alcohol or substance abuse within the past 12 months\n* History of dementia","65 Years",{"count":200,"type":23},270,[26],"This research is being done to assess whether an exercise intervention with protein intake support vs a health education and support program will make it easier for women age 65 or older who are receiving chemotherapy for breast cancer to receive all of their planned chemotherapy according to schedule and at the planned dose.",[29,204,31,205,206],"Stage III Breast Cancer","Stage I Breast Cancer","Stage II Breast Cancer",[29,204,206,205,208,209,210],"Exercise Intervention","Nutrition Intervention","Supportive Care","2026-07-16",{"date":213,"type":41},"2026-07-17",{"date":215,"type":41},"2023-03-20",{"date":217,"type":23},"2028-02-01",{"name":134,"class":48},{"id":220,"slug":221,"hasResults":12,"nctId":222,"briefTitle":223,"officialTitle":224,"acronym":4,"eligibilityCriteria":225,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":226,"enrollmentInfo":227,"targetDuration":4,"studyType":24,"phases":229,"briefSummary":230,"conditions":231,"keywords":233,"overallStatus":237,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":4},"100547253","physical-activity-for-adults-in-the-ontario-breast-screening-program-100547253","NCT06405568","Physical Activity for Adults in the Ontario Breast Screening Program","Support for Physical Activity for Adults Registered in the Ontario Breast Screening Program: A Randomized Controlled Trial","Inclusion Criteria:\n\n* English- and French-speaking adults enrolled in the Ontario Breast Screening Program;\n* Aged 30-69 years;\n* Assigned female sex at birth;\n* Be at high risk for breast cancer as identified through Category A or B, after genetic assessment: (a) Category A individuals meet ≥1 of the following criteria: (i) known carrier of a gene mutation (e.g., BRCA1, BRCA2), (ii) first degree relative of a carrier of a gene mutation (e.g., BRCA1, BRCA2), received genetic counselling but declined genetic testing, (iii) previously assessed as having ≥25% lifetime risk of breast cancer on basis of family history, or (iv) received chest radiation before age 30 and ≥ 8 years previously.\n\n  (b) Category B individuals meet ≥1 of the following criteria: (i) first degree relative of a carrier of a gene mutation (e.g., BRCA1, BRCA2), has not had genetic counselling or testing, (ii) a personal or family history of ≥1 of the following: ≥2 cases of breast cancer and\u002For ovarian cancer in closely related blood relatives, bilateral breast cancer, both breast cancer and ovarian cancer in the same individual, breast cancer at age ≤35 years, invasive serous ovarian cancer, breast cancer and\u002For ovarian cancer in Ashkenazi Jewish families, an identified gene mutation (e.g., BRCA1, BRCA2) in any blood relative, male breast cancer.\n\nExclusion Criteria:\n\nIndividuals self-reporting\n\n* \\>150 minutes of moderate-to-vigorous intensity physical activity in the past week;\n* no access to an internet connected device;\n* a condition preventing physical activity (e.g., uncontrolled hypertension)","69 Years",{"count":228,"type":23},200,[26],"There is \"strong\" evidence that physical activity (PA) can reduce the risk of breast cancer (Bernstein, 2009; Kehm et al., 2020), which is important for individuals at higher-than-average risk due to their family history or genetic susceptibility. PA can also enhance quality of life (QoL), fitness, and surrogate markers (e.g., weight) linked to cancer prognosis (Ligibel et al., 2019; Patel et al., 2019). Despite this evidence, most adults are insufficiently active, meaning they do not meet Canadian recommendations of at least 150 minutes of PA each week (Statistics Canada, 2020). This study aims to develop materials that can help increase the number of adults at higher-than-average risk who meet PA recommendations, alongside improving QoL and body mass index (BMI; a measure of one's body weight-height ratio). Participants will include individuals assigned female at birth, aged 30-69 years, at high-risk of breast cancer registered in the Ontario Breast Screening Program who will be randomly assigned to receive (1) the intervention, which includes a copy of PA recommendations (Canadian Society for Exercise Physiology \\[CSEP\\] recommendations for adults plus content spotlighting PA benefits) plus a PA motivation package featuring three online webinars (explaining PA benefits and how to get started), digitized PA materials (providing evidence-based tools to modify behaviour), and a digitized logbook (to track PA) or (2) only a copy of PA recommendations.",[31,232],"Physical Inactivity",[234,235,236],"Healthcare providers","Physical activity","Breast cancer","NOT_YET_RECRUITING","2026-07-09",{"date":240,"type":41},"2026-07-10",{"date":242,"type":23},"2026-08-01",{"date":244,"type":23},"2028-08-01",{"name":246,"class":48},"University of Ottawa",{"id":248,"slug":249,"hasResults":12,"nctId":250,"briefTitle":251,"officialTitle":252,"acronym":253,"eligibilityCriteria":254,"healthyVolunteers":12,"sex":18,"minAge":198,"maxAge":4,"enrollmentInfo":255,"targetDuration":4,"studyType":24,"phases":257,"briefSummary":258,"conditions":259,"keywords":260,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":271,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":277,"locationsCount":49},"100555094","phase-3-pre-operative-window-of-et-to-inform-rt-decisions-power-ii-100555094","NCT06507618","Pre-Operative Window of ET to Inform RT Decisions (POWER II)","A Randomized, Phase III Trial of Pre-Operative Window of Endocrine Therapy to Inform Radiation Therapy Decisions in Older Women With Early-Stage Breast Cancer (POWER II)","POWER II","Inclusion Criteria (summary):\n\n* Diagnosis of ER+, PR +\u002F-, and HER2- non amplified invasive breast cancer and clinically negative nodes\n* ECOG performance status 0-2\n* Females, aged ≥ 65 years\n* Patient is eligible for BCS and opted for BCS\n* Patient is a candidate for radiation therapy\n* Patient is a candidate for endocrine therapy (tamoxifen or an aromatase inhibitor)\n* Ability to take oral medication and be willing to adhere to endocrine therapy for the 3-month period prior to BCS\n* Agreement to adhere to Lifestyle Considerations (details in protocol) throughout study duration\n* Provision of signed and dated informed consent form\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n\nExclusion Criteria:\n\n* Bilateral synchronous breast cancer\n* Multicentric disease\n* Prior use of Tamoxifen or aromatase inhibitors\n* History of ipsilateral breast radiation therapy\n* Has a known additional malignancy that is progressing and\u002For requires active treatment with cytotoxic chemotherapy or radiation therapy. Malignancies deemed stable and low risk for complication per investigator's judgment may be allowed after discussion with multi-site PI.\n* Current or planned use of a strong CYP2D6 inhibitor (e.g., Fluvoxamine, Paroxetine) and is not able to receive an endocrine therapy agent that does not use the CYP2D6 pathway.",{"count":256,"type":23},354,[87],"This is a Phase III, multisite exploratory study for women ≥ 65 years of age with early stage estrogen receptor positive (ER+) breast cancer. These individuals will be treated randomly assigned to one of two groups:\n\nIntervention, treated with 3 months of pre-operative endocrine therapy (pre-ET) OR Control, participants follow standard of care and proceed directly to breast cancer surgery.\n\nBoth arms will be assessed for tolerance and compliance to the endocrine therapy by patient reported outcome (PRO) measures (patient surveys).",[31],[177,261,262,263,264,265,266,267,268,269],"endocrine therapy","radiation","letrozole","anastrozole","exemestane","tamoxifen","survey","questionnaire","geriatric","2026-06-25",{"date":272,"type":41},"2026-06-30",{"date":274,"type":41},"2024-07-19",{"date":276,"type":23},"2034-03-01",{"name":278,"class":48},"University of Virginia",{"id":280,"slug":281,"hasResults":12,"nctId":282,"briefTitle":283,"officialTitle":284,"acronym":285,"eligibilityCriteria":286,"healthyVolunteers":12,"sex":18,"minAge":83,"maxAge":4,"enrollmentInfo":287,"targetDuration":4,"studyType":24,"phases":289,"briefSummary":290,"conditions":291,"keywords":292,"overallStatus":237,"whyStopped":4,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":298,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":304,"locationsCount":4},"100642611","safety-feasibility-and-outcomes-of-early-rehabilitation-after-breast-cancer-surgery-100642611","NCT07651696","Safety, Feasibility, and Outcomes of Early Rehabilitation After Breast Cancer Surgery","Evaluation of the Safety, Feasibility, and Functional Outcomes of a Structured Early Rehabilitation Protocol Following Breast Cancer Surgery: A Prospective Study in Routine Clinical Practice.","EMOVE-BCS","Inclusion Criteria:\n\n* Women aged ≥18 years undergoing breast cancer surgery at Hospital Universitari i Politècnic La Fe and referred to the early postoperative rehabilitation programme through the usual care pathway.\n* Any type of breast surgery, including breast-conserving surgery and\u002For mastectomy, with or without reconstruction\u002Fprosthesis, and bilateral surgery.\n* Any type of axillary surgery, including sentinel lymph node biopsy (SLNB) and\u002For axillary lymph node dissection (ALND).\n* Patients undergoing surgery for recurrence and\u002For reoperation, for example margin widening, reoperation due to complications, or reoperation for oncological reasons, provided that it is clinically possible to start the programme.\n* Ability to understand instructions, complete questionnaires, and sign the informed consent form.-\n\nExclusion Criteria:\n\n* Inability to safely start the protocol during the first postoperative weeks due to medical or surgical contraindication, or due to severe clinical complications, for example the need for strict immobilization, specific restrictions, or prolonged hospital admission, according to the criteria of the surgical team or the rehabilitation service, preventing the protocol from being initiated according to the usual care schedule.\n* Severe pre-existing upper limb condition, unilateral or bilateral, causing significant limitation of mobility or function before surgery and making the interpretation of clinical progression unreliable, for example shoulder arthroplasty, recent fracture, frozen shoulder in the inflammatory phase with severe limitation, or untreated massive rotator cuff tear with marked functional impairment.\n* Severe neurological or musculoskeletal disease that significantly affects upper limb function and may influence the main outcome variables, for example stroke with major sequelae, spinal cord injury, or severe neuropathy.\n* Cognitive impairment, severe decompensated psychiatric disorder, or language barrier without available support, preventing the participant from understanding instructions and completing assessments.\n* Participation in another study that may substantially interfere with the results, according to the investigator's judgment.",{"count":288,"type":23},110,[26],"Breast cancer is one of the most common tumours in women. Advances in diagnosis and treatment have increased survival, but many women experience functional sequelae after breast and\u002For axillary surgery, including pain, reduced shoulder range of motion, loss of strength, difficulties in daily activities, axillary web syndrome, and possible lymphoedema. These impairments may affect autonomy, self-care, return to daily life, and correct arm positioning during adjuvant treatments such as radiotherapy.\n\nAlthough therapeutic exercise and rehabilitation are recommended within oncology care, the implementation of early rehabilitation programmes after breast cancer surgery remains variable. This study aims to evaluate a structured, individualised, and supervised early rehabilitation protocol, EMOVE-BCS-LaFe, applied in routine clinical practice during the first three months after surgery.\n\nThe main hypothesis is that the protocol is safe and feasible, with a low frequency of physiotherapy-related adverse events requiring urgent care or programme suspension for more than 7 days, and high completion and adherence rates. Secondary outcomes include improvements in shoulder mobility, pain, upper limb function, strength, overall functional capacity, satisfaction, and differences according to type of breast and axillary surgery.\n\nA prospective, single-centre, observational, single-arm cohort study will be conducted at HUIP La Fe. Adult women undergoing breast cancer surgery and referred to the programme will be consecutively included. The intervention includes preoperative education, therapeutic exercise initiated from the first postoperative day, home-based and supervised sessions, individualised progression, self-care recommendations, and early detection and management of axillary web syndrome and lymphoedema.\n\nFollow-up will extend from preoperative assessment to three months after surgery. Safety, adherence, programme completion, range of motion, pain, upper limb function, shoulder strength, functional capacity, and satisfaction will be assessed using adverse event records, adherence data, goniometry, VAS, QuickDASH, dynamometry, 30-second Sit-to-Stand test, CSQ-8, and specific satisfaction items. Data analysis will be descriptive, estimating proportions, clinical-functional changes over time, and exploratory differences according to surgery type.",[31],[293,294,295,296],"Breast cancer surgery","Postoperative rehabilitation","Early rehabilitation","Physical Therapy","2026-06-11",{"date":299,"type":41},"2026-06-16",{"date":301,"type":23},"2026-09-01",{"date":303,"type":23},"2027-08",{"name":305,"class":48},"Marta Aguilar-Rodriguez",{"id":307,"slug":308,"hasResults":12,"nctId":309,"briefTitle":310,"officialTitle":311,"acronym":312,"eligibilityCriteria":313,"healthyVolunteers":12,"sex":18,"minAge":83,"maxAge":4,"enrollmentInfo":314,"targetDuration":4,"studyType":24,"phases":316,"briefSummary":317,"conditions":318,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":324,"startDateStruct":326,"completionDateStruct":327,"leadSponsor":329,"locationsCount":135},"100514745","phase-2-18f-fes-petmri-for-tailoring-treatment-of-luminal-a-and-lobular-breast-cancer-100514745","NCT05982496","18F FES-PET\u002FMRI for Tailoring Treatment of Luminal A and Lobular Breast Cancer","18F-FES PET\u002FMRI for Tailoring Treatment of Luminal A and Lobular Breast Cancer: a Phase II Prospective Cohort Study Evaluating the Performance of FES PET\u002FMRI in Axillary Staging Compared With Axillary Surgery","FESTA","Inclusion Criteria:\n\n* Female patients, age\\>= 18 yrs, diagnosed with primary or advanced breast cancer\n* LumA or ER-positive Lobular subtypes\n\n  * candidates to surgery as first treatment regardless of cN\n  * ER-positive Her2 negative BC with ki67\\>10%\n\nExclusion Criteria:\n\n* ER-negative tumors\n* Pregnancy;\n* Contraindication to PET;\n* Contraindication to MRI;\n* Claustrophobia;\n* Allergy to the MR contrast agent;\n* Severe renal insufficiency",{"count":315,"type":23},119,[117],"Study hypothesis is that combining the advantages of hybrid PET\u002FMRI and the high sensitivity\u002Fspecificity of 16-alpha-18F-fluoro-17-beta-estradiol(FES), a radiolabeled form of estrogen binding to functionally active ER, the investigators could obtain a reliable, non-invasive, operator-independent, one-stage imaging method for staging LumA and ER-positive Lobular tumours.",[31,319,320,321,322],"Lobular Breast Carcinoma","PET\u002FMRI","Axillary Lymphadenopathy","Luminal A Breast Cancer","2026-06-09",{"date":325,"type":41},"2026-06-12",{"date":323,"type":41},{"date":328,"type":23},"2029-12-01",{"name":330,"class":48},"Università Vita-Salute San Raffaele",{"id":332,"slug":333,"hasResults":12,"nctId":334,"briefTitle":335,"officialTitle":335,"acronym":336,"eligibilityCriteria":337,"healthyVolunteers":12,"sex":113,"minAge":83,"maxAge":4,"enrollmentInfo":338,"targetDuration":4,"studyType":24,"phases":340,"briefSummary":342,"conditions":343,"keywords":346,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":350,"lastUpdatePostDateStruct":351,"startDateStruct":353,"completionDateStruct":355,"leadSponsor":357,"locationsCount":135},"100608220","phase-1-eradicate-a-phase-ibii-study-of-elacestrant-plus-trastuzumab-deruxtecan-in-patients-with-cdk46-inhibitor-and-endocrine-resistant-hrher2-low-or-her2-ultralow-metastatic-breast-cancer-100608220","NCT07198724","ERADICATE: A Phase Ib\u002FII Study of Elacestrant Plus Trastuzumab Deruxtecan in Patients With CDK4\u002F6 Inhibitor and Endocrine-resistant HR+\u002FHER2-low or HER2-ultralow Metastatic Breast Cancer","ERADICATE","Inclusion Criteria:\n\n* Participants must have a histologically or cytologically confirmed diagnosis of HR+\u002FHER2-low metastatic or unresectable locally advanced breast cancer, defined as ER ≥ 10%, any PR in the most recent sample and HER2-low (IHC 1+ or IHC 2+ and ISH non-amplified) or HER2-ultralow (IHC 0 and any membranous staining on any prior primary or metastatic sample). Cutoff values for positive\u002Fnegative HER2 staining should be in accordance with current ASCO\u002FCAP (American Society of Clinical Oncology\u002FCollege of American Pathologists) guidelines.76\n* Participants must have had prior CDK4\u002F6 inhibitor and may have any number of prior endocrine based therapies in the metastatic setting.\n* Participants may have progressed on up to 1 prior line of prior chemotherapy or ADC in the metastatic setting.\n* Participants must have measurable disease per RECIST 1.1 criteria. See Section 11 for the definition of measurable disease. Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm (≥2 cm) by chest x-ray or as ≥10 mm (≥1 cm) with CT scan, MRI, or calipers by clinical exam. See Section 12 (Measurement of Effect) for the evaluation of measurable disease.\n* Participants must have known ESR1 mutation status in tumor or ctDNA within 6 months of enrollment to the trial. Participants must have Guardant360 CDx testing for ESR1-mutation status if status has not been validated within 60 days of registration.\n* Women or men age ≥18 years are eligible.\n* ECOG performance status ≤ 2.\n* Participants must have adequate organ and marrow function as defined below:\n\n  * Absolute neutrophil count ≥ 1,500\u002FµL\n  * Platelets ≥ 100,000\u002FµL\n  * Hemoglobin ≥ 9.0 g\u002FdL\n  * Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (or ≤ 2 x ULN in patients with documented Gilbert's syndrome)\n  * AST(SGOT)\u002FALT(SGPT) ≤ 2.5 x institutional ULN (or \\\u003C 5 x ULN in patients with liver metastases)\n  * Creatinine ≤ 1.5 x institutional ULN OR\n  * Calculated creatinine clearance ≥ 45 mL\u002Fmin via the Cockcroft-Gault formula for participants with creatinine levels above institutional ULN\n  * Baseline LVEF ≥ 50% prior to registration, as measured by echocardiogram (or multiple-gated acquisition \\[MUGA\\] scan if an echocardiogram cannot be performed or is inconclusive).\n  * Participants with a history of central nervous system (CNS) metastases are eligible if: Stable or untreated, asymptomatic brain metastases not needing immediate local therapy. For patients with untreated CNS lesions \\> 2.0 cm on screening contrast brain MRI, discussion with and approval from the Sponsor Investigator is required prior to enrollment.\n\n    1. Brain metastases previously treated with local therapy may either be stable since treatment or may have progressed since prior local CNS therapy, provided that there is no clinical indication for immediate re-treatment with local therapy in the opinion of the investigator\n    2. Patients treated with CNS local therapy for newly identified lesions may be eligible to enroll if all of the following criteria are met: Time since WBRT is ≥ 14 days prior to first dose of treatment, time since SRS is ≥ 7 days prior to first dose of treatment, and time since surgical resection is ≥ 14 days\n* Postmenopausal women must be postmenopausal, which is defined as any of the following:\n\n  * Age ≥ 60 years\n  * Age \\\u003C 60 and amenorrhea for 12 or more months (in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression) and FSH, and estradiol in the postmenopausal range per local normal range\n  * Premenopausal women made postmenopausal through the use GnRH agonist prior to study entry are eligible and MUST remain on the GnRH agonist for the duration of protocol treatment.\n  * Status-post bilateral oophorectomy - After adequate healing post-surgery\n* Premenopausal women must have a negative serum or urine pregnancy test. Pregnancy testing does not need to be pursued in female participants who are postmenopausal according to the definition in 3.1.10.\n* Women of child-bearing potential and men must agree to use adequate contraception at time of enrollment and for 4 months after the last dose of elacestrant or 7 months after the last dose of trastuzumab deruxtecan, whichever is later.\n* Participants must be able to swallow and retain oral medication.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Prior treatment with aatopoisomerase inhibitor antibody drug conjugate in any setting.\n* Prior treatment with an oral novel estrogen receptor degrader or modulator in the metastatic setting (SERD, SERM, PROTAC, or CERAN). Prior fulvestrant is allowed. A washout period of 7 days is required for any endocrine or targeted therapy. A washout period of 14 days is required for any chemotherapy.\n* Patients with known brain metastases that are symptomatic or that require therapy for symptom control are not eligible. Patients with stable or asymptomatic brain metastases are allowed. Participants with CNS metastases treated by neurosurgical resection or brain biopsy performed within 4 weeks before day 1 of study therapy will be excluded.\n* Receipt of any other investigational compound or device within 2 weeks of the first dose of treatment in this study.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to elacestrant or T-DXd.\n* History of (non-infectious) pneumonitis that required steroids or current ILD by imaging at screening.\n* Patients who are pregnant or breastfeeding, or who expect to become pregnant within the projected duration of the study.\n* Patients with active tuberculosis.\n* Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection requiring systemic therapy, clinically significant cardiovascular disease including: cerebral vascular accident\u002Fstroke (\\\u003C 6 months prior to enrollment), myocardial infarction (\\\u003C 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication, uncontrolled diabetes mellitus, gastrointestinal disorders potentially affecting the absorption of elacestrant, inflammatory bowel disease or chronic diarrhea, short bowel syndrome, or total gastric resection, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements. Moderate or severe hepatic impairment (Child-Pugh B or C). Active hepatitis B or active hepatitis C infection. Ability to comply with study requirements is to be assessed by each investigator at the time of screening for study participation. History of myocardial infarction, acute coronary syndrome or coronary angioplasty\u002Fstenting\u002Fbypass grafting within the last six months OR congestive heart failure (CHF) New York Heart Association (NYHA) Class II-IV or history of CHF NYHA Class III or IV.\n* Patients with a history of different malignancy are ineligible, except for those who have been disease-free for at least three years and are deemed by the investigator to be at low risk for recurrence of the prior malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: ductal carcinoma in situ of the breast, cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.",{"count":339,"type":23},65,[341,117],"PHASE1","The goal of this study is to evaluate the safety and efficacy of elacestrant in combination with trastuzumab deruxtecan (T-DXd) in participants with hormone receptor-positive (HR+), HER2-low or HER2-ultralow, metastatic breast cancer that is resistant to prior CDK4\u002F6 inhibitor and endocrine therapy.\n\nThe names of the study drugs involved in this study are:\n\n* Elacestrant (a type of selective estrogen receptor degrader)\n* Trastuzumab deruxtecan (a type of standard of care antibody drug conjugate)",[344,345,150,29,31],"Metastatic Breast Cancer","HER2 Low Breast Carcinoma",[344,345,150,29,31,347,348,349],"HR+\u002FHER2-low Breast Cancer","HR+\u002FHER2-ultralow Breast Cancer","Endocrine-resistant Breast Cancer","2026-06-08",{"date":352,"type":41},"2026-06-10",{"date":354,"type":41},"2025-11-17",{"date":356,"type":23},"2038-06-01",{"name":358,"class":48},"Kristina A. Fanucci",{"id":360,"slug":361,"hasResults":12,"nctId":362,"briefTitle":363,"officialTitle":364,"acronym":365,"eligibilityCriteria":366,"healthyVolunteers":12,"sex":18,"minAge":83,"maxAge":4,"enrollmentInfo":367,"targetDuration":4,"studyType":62,"phases":4,"briefSummary":369,"conditions":370,"keywords":4,"overallStatus":237,"whyStopped":4,"lastUpdateSubmitDate":350,"lastUpdatePostDateStruct":371,"startDateStruct":372,"completionDateStruct":374,"leadSponsor":376,"locationsCount":135},"100593455","anatomical-landmarks-for-chest-wall-perforators-used-for-partial-breast-reconstruction-100593455","NCT07006662","Anatomical Landmarks for Chest Wall Perforators Used for Partial Breast Reconstruction","Anatomical Landmarks for Chest Wall Perforators Used for Partial Breast Reconstruction (LaPBrecon)","(LaPBrecon)","Inclusion Criteria:\n\n* Patients undergoing elective breast surgery\n* Age ≥ 18 years\n* Female\n* BMI ≤ 30 kg\u002Fm2\n* Willing and able to give fully informed consent,\n* Willing and able to comply with the study procedures\n\nExclusion Criteria:\n\n* Pregnant patients\n* Previous bilateral Breast or axillary surgery\n* Undergoing bilateral oncoplastic procedure or requiring bilateral pre-operative marking\n* Undergoing breast surgery requiring pre-operative marking of some of the landmarks and has had contralateral breast or axillary surgery in the past\n* Surgery planned within 24 hours of screening for eligibility\n* Known history of allergy or contact dermatitis to ultrasound gels",{"count":368,"type":23},20,"The aim of this 6-month proof-of-concept study is to map out the chest wall perforators in relation to anatomical landmarks for partial breast reconstruction.",[31],{"date":323,"type":41},{"date":373,"type":23},"2026-07-01",{"date":375,"type":23},"2027-12-01",{"name":377,"class":48},"University Hospitals of North Midlands NHS Trust",{"id":379,"slug":380,"hasResults":12,"nctId":381,"briefTitle":382,"officialTitle":383,"acronym":384,"eligibilityCriteria":385,"healthyVolunteers":12,"sex":18,"minAge":83,"maxAge":4,"enrollmentInfo":386,"targetDuration":4,"studyType":24,"phases":388,"briefSummary":389,"conditions":390,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":392,"lastUpdatePostDateStruct":393,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":399,"locationsCount":135},"100602176","transcranial-magnetic-stimulation-for-chemotherapy-induced-peripheral-neuropathy-in-breast-and-gynecologic-cancer-survivors-100602176","NCT07120100","Transcranial Magnetic Stimulation for Chemotherapy-Induced Peripheral Neuropathy in Breast and Gynecologic Cancer Survivors","Repetitive Transcranial Magnetic Stimulation for Chemotherapy-Induced Peripheral Neuropathy (CIPN) in Breast and Gynecologic Cancer Survivors: A Pilot Study","rTMS for CIPN","Inclusion Criteria:\n\n* Female subjects aged ≥ 18 years.\n* Histologically confirmed breast or gynecologic cancer.\n* Developed neuropathic pain with the initiation of or within one month after completion of treatment with anti-neoplastic agents from the following class:\n\n  * Platinum-based drugs\n  * Taxanes\n  * Vinca alkaloids\n* Pain score 4 or more on the Pain Numeric Rating Scale (PNRS).\n* Score 3 or more on the Douleur Neuropathique 4 (DN-4) questionnaire.\n* Subjects must have failed at least one standard-of-care neuropathic medication.\n\n  \\--- Note: Failure is defined as discontinuation of the standard-of-care neuropathic pain medication due to intolerable side effects or lack of analgesic benefit after continuing the medication for at least 6 weeks.\n* Subjects who are currently on neuropathic medication must have been on a stable dose for at least 6 weeks prior to enrollment.\n\n  \\-- Note: Additional washout periods for other pain medications may be needed and will be determined by the Investigator.\n* For female subjects: Negative pregnancy test or evidence of post-menopausal status. The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause or having undergone surgical sterilization (bilateral oophorectomy or hysterectomy). The following age-specific requirements apply:\n\n  * Women \\\u003C 50 years of age:\n\n    * Amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and\n    * Luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution; or\n    * Underwent surgical sterilization (bilateral oophorectomy or hysterectomy).\n  * Women ≥ 50 years of age:\n\n    * Amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or\n    * Had radiation-induced menopause with last menses \\>1 year ago; or\n    * Had chemotherapy-induced menopause with last menses \\>1 year ago; or\n    * Underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy).\n* Subjects of childbearing potential must agree to use a highly effective method of contraception as described in Section 5.4.1.\n* Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.\n\nExclusion Criteria:\n\n* Evidence of recurrent breast or gynecologic cancer at the time of enrollment.\n* Current or planned treatment with chemotherapy.\n\n  --Note: Other anti-cancer treatments (e.g. hormone therapy and targeted therapies) are allowed at the Investigator's discretion.\n* History of seizure, epilepsy, or other conditions that would, in the opinion of the investigator, negatively impact the patient's safety or ability to participate in the study.\n* Presence of neuropathic pain unrelated to systemic cancer therapy, including but not limited to: painful diabetic neuropathy, HIV-induced neuropathy, neuropathic pain from radiation therapy and underlying cancer\u002Fother medical conditions.\n* Presence of implantable devices including spinal cord stimulators, dorsal root ganglion stimulators, deep brain stimulators, cochlear implants, intrathecal pain pumps, and intracranial metallic objects which are incompatible with rTMS administration in the opinion of the treating investigator.\n* Subjects on medications that, in the opinion of the investigator, significantly lower seizure threshold will be excluded.\n* Any condition that would, in the Investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures.\n* History of recent suicide attempt or active suicidal ideation that, in the opinion of the investigator, presents an increased risk for study participation\n* Medical, psychiatric, cognitive, or other conditions that may compromise the subject's ability to understand the subject information, give informed consent, comply with the study protocol or complete the study.\n* Enrollment in another study that, in the opinion of the investigator, would negatively impact study participation or cause undue burden for the subject.",{"count":387,"type":23},19,[26],"The goal of this study is to evaluate the change in pain scores among patients with chemotherapy-induced peripheral neuropathy after receiving treatment with repetitive transcranial magnetic stimulation (rTMS).",[31,391],"Gynecologic Cancer","2026-05-29",{"date":394,"type":41},"2026-06-02",{"date":396,"type":41},"2025-08-27",{"date":398,"type":23},"2028-09-15",{"name":400,"class":48},"University of Utah",{"id":402,"slug":403,"hasResults":12,"nctId":404,"briefTitle":405,"officialTitle":406,"acronym":4,"eligibilityCriteria":407,"healthyVolunteers":12,"sex":18,"minAge":408,"maxAge":4,"enrollmentInfo":409,"targetDuration":4,"studyType":24,"phases":411,"briefSummary":412,"conditions":413,"keywords":415,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":418,"lastUpdatePostDateStruct":419,"startDateStruct":420,"completionDateStruct":422,"leadSponsor":424,"locationsCount":75},"100601873","exercise-therapy-and-cognitive-behavioural-therapy-for-fatigue-in-female-cancer-patients-in-singapore-100601873","NCT07116161","Exercise Therapy and Cognitive Behavioural Therapy for Fatigue in Female Cancer Patients in Singapore","Pilot Study of Exercise Therapy and Cognitive Behavioural Therapy for Fatigue in Female Cancer Patients in Singapore","Inclusion Criteria:\n\nPrimary cohort (N=90):\n\n1. Female\n2. ≥21 years of age\n3. Stage I-III breast cancer regardless of hormone receptor status or human epidermal growth factor receptor 2 (HER2) status\n4. Completed surgery\n5. Completed adjuvant chemotherapy, if indicated\n6. Reported fatigue (One-item fatigue scale score ≥ 4)\n7. Ability to read and communicate in English\n8. Willing to provide informed consent for the study participation\n\nExploratory cohort (N=10):\n\n1. Female\n2. ≥21 years of age\n3. Stage IV breast cancer regardless of hormone receptor status or human epidermal growth factor receptor 2 (HER2) status\n4. Completed surgery\n5. Currently receiving systemic therapy (e.g. endocrine therapy, chemotherapy, targeted therapy or immunotherapy)\n6. Reported fatigue (One-item fatigue scale score ≥ 4)\n7. Ability to read and communicate in English\n8. Willing to provide informed consent for the study participation\n\nExclusion Criteria for both cohorts:\n\n1. Pregnant or lactating\n2. Presence of dementia or major psychiatric disease\n3. Deemed medically unsuitable by medical team for low to moderate intensity exercise\n4. Unable or unwilling for tele-counselling sessions\n5. Uncontrolled pain or undiagnosed pain\n6. Low blood counts: Hb \\\u003C8.0, Platelet \\\u003C50K, ANC \\\u003C1\n7. Electrolyte imbalances: K \\\u003C3.0, Na \\\u003C130\n8. Cardiovascular diseases, including but not limited to: LVEF \\\u003C35%, uncontrolled arrhythmias, severe coronary artery disease, severe valvular heart disease, uncontrolled hypertension etc. not cleared by a cardiologist\n9. Active infection\n10. Currently engaged in moderate to vigorous physical activity","21 Years",{"count":410,"type":23},100,[26],"The purpose of this research study is to investigate the acceptability, feasibility, and effectiveness of exercise therapy and cognitive behavioral therapy (CBT) in improving fatigue levels and breast cancer treatment adherence in breast cancer patients.",[414,31],"Fatigue",[416,417],"Exercise Therapy","Cognitive Behavioural Therapy","2026-05-27",{"date":392,"type":41},{"date":421,"type":41},"2025-07-14",{"date":423,"type":23},"2027-12-31",{"name":425,"class":48},"National Cancer Centre, Singapore",{"id":427,"slug":428,"hasResults":12,"nctId":429,"briefTitle":430,"officialTitle":431,"acronym":432,"eligibilityCriteria":433,"healthyVolunteers":12,"sex":18,"minAge":83,"maxAge":198,"enrollmentInfo":434,"targetDuration":4,"studyType":24,"phases":436,"briefSummary":437,"conditions":438,"keywords":439,"overallStatus":237,"whyStopped":4,"lastUpdateSubmitDate":447,"lastUpdatePostDateStruct":448,"startDateStruct":450,"completionDateStruct":451,"leadSponsor":453,"locationsCount":135},"100555908","preventing-breast-cancer-therapy-related-cardiovascular-toxicity-with-a-daily-adapted-program-with-mhealth-support-100555908","NCT06518200","Preventing Breast Cancer Therapy-related Cardiovascular Toxicity With a Daily-adapted Program With Mhealth Support","ATOPE-PRO: Effects on the Prevention of Breast Cancer Therapy-related Cardiovascular Toxicity of a Daily-adapted and Individualized Program With Support From a Mobile Application","ATOPE-PRO","Inclusion Criteria:\n\n* Recently diagnosed with stage I-III breast cancer\n* Treatments predisposing to cardiotoxicity (anthracyclines, targeted therapies, radiotherapy)\n* Signed informed consent form\n* Medical authorisation to participate\n* Smartphone user level\n\nExclusion Criteria:\n\n* Patient underwent previous cancer treatments.\n* Patients were previously diagnosed with cancer\n* Pregnant patients. Patients performing other type of therapeutic exercise at diagnosis time with an intake \\>or = to 150 moderate-intensity or 75 min of vigorous-intensity a day\n* Therapeutic exercise practice not recommended because psychiatric or cognitive disorders or cute or chronic condition that prevents exercise (advanced lung disease, oxygen requirement, stenosis \\>70%, metastasis etc.).",{"count":435,"type":23},102,[26],"ATOPE-PRO, was developed with the intention of consolidating the integration of an innovative system for the prevention of cancer therapy-related cardiovascular toxicity (CTR-CVT) in the continuum care of women with breast cancer in health services. It is a step further towards personalized medicine by optimizing the already available tools and integrating artificial intelligence. Breast cancer survival increases every year, a situation that poses new challenges for health professionals. The European Society for Medical Oncology, a reference in Europe, has just highlighted the need to anticipate to and prevent sequelae derived from the disease and its treatments. This, in addition to having a positive impact on improving the quality of life of people suffering from this disease, would mean a reduction in the risk of recurrence, the appearance of other tumors and other diseases, and death from cancer or other causes, which have a personal impact and represent an overload of the healthcare system. To this end, ATOPE- PRO aims to optimize and refine tools already developed in the previous project (ATOPE, Pl18\u002F01840), integrating artificial intelligence to help identify CTR-CVT, risk profiles, and effective and safe doses (at a clinical level) early on, implementing the program in a longer term, and transferring the results to the social sector (social level). The project has 4 stages: Phase 0 or start-up (to make improvements and analyse usability); Phase 1 for piloting and optimization; Phase 2, to verify efficacy (randomized controlled clinical trial) and Phase 3, in which a deep analysis will be performed and future projects will be conceived.",[31],[30,440,441,442,443,444,445,446],"Cancer therapy-related cardiovascular toxicity","Physical Exercise","Prevention","Quality of life","Rehabilitation","Telemedicine","Health related lifestyle","2026-04-30",{"date":449,"type":41},"2026-05-06",{"date":301,"type":23},{"date":452,"type":23},"2028-12-31",{"name":454,"class":48},"Universidad de Granada",{"id":456,"slug":457,"hasResults":12,"nctId":458,"briefTitle":459,"officialTitle":460,"acronym":461,"eligibilityCriteria":462,"healthyVolunteers":12,"sex":18,"minAge":463,"maxAge":20,"enrollmentInfo":464,"targetDuration":466,"studyType":62,"phases":4,"briefSummary":467,"conditions":468,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":470,"lastUpdatePostDateStruct":471,"startDateStruct":473,"completionDateStruct":475,"leadSponsor":477,"locationsCount":135},"100558783","evaluation-of-safety-of-acellular-dermal-matrixadm-in-breast-reconstruction-100558783","NCT06555614","Evaluation of Safety of Acellular Dermal Matrix(ADM) in Breast Reconstruction","Prospective and Retrospective, Single Center, Case-control, Investigator-initiated, Observational Study to Evaluate the Safety of Acellular Dermal Matrix Processed by the Supercritical CO2 Technology in Breast Reconstruction With Implants","ADM","Inclusion Criteria\n\nProspective Subjects (Test Group):\n\n* Female patients aged 19 to 79 years\n* Patients undergoing implant-based breast reconstruction using SC DERM® Recon (an acellular dermal matrix product) following mastectomy due to breast cancer\n* Patients who voluntarily provide written informed consent after receiving a full explanation of the study objectives and procedures, and who are willing and able to comply with the study protocol and scheduled visits\n\nRetrospective Medical Record Collection (Control Group):\n\n* Patients who underwent implant-based breast reconstruction using an acellular dermal matrix product following mastectomy due to breast cancer at Seoul National University Hospital\n* Availability of medical records between March 1, 2021, and March 31, 2024\n\nExclusion Criteria\n\nProspective Subjects (Test Group):\n\n\\- Patients deemed inappropriate for participation in the study by the principal investigator or sub-investigator (e.g., inability to undergo required assessments)\n\nRetrospective Medical Record Collection (Control Group):\n\n\\- Patients with no recorded follow-up visits after application of the acellular dermal matrix","19 Years",{"count":465,"type":23},120,"12 Weeks","The goal of this observational study is to evaluate the safety of Acellular Dermal Matrix(ADM) processed by CO2 supercritical fluid technology against other acellular dermal matrix products from different companies that have been washed with detergents in patients undergoing breast reconstruction surgery with implants due to the breast cancer.",[31,469],"Breast Reconstruction","2026-04-23",{"date":472,"type":41},"2026-04-28",{"date":474,"type":41},"2024-06-13",{"date":476,"type":23},"2027-02-28",{"name":478,"class":74},"DOF Inc.",{"id":480,"slug":481,"hasResults":12,"nctId":482,"briefTitle":483,"officialTitle":484,"acronym":4,"eligibilityCriteria":485,"healthyVolunteers":17,"sex":18,"minAge":408,"maxAge":4,"enrollmentInfo":486,"targetDuration":4,"studyType":62,"phases":4,"briefSummary":488,"conditions":489,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":491,"lastUpdatePostDateStruct":492,"startDateStruct":494,"completionDateStruct":496,"leadSponsor":498,"locationsCount":135},"100296293","effects-of-chemotherapy-on-cognitive-function-in-breast-cancer-patients--non-cancer-control-subjects-with-optional-sub-study-research-brain-mri-100296293","NCT03137095","Effects of Chemotherapy on Cognitive Function in Breast Cancer Patients & Non-Cancer Control Subjects With Optional Sub-Study Research Brain MRI","Longitudinal Pilot Mechanistic Study of the Effects of Chemotherapy on Cognitive Function in Breast Cancer Patients and Non-Cancer Control Participants - Optional Sub-Study: Research Brain MRI","Inclusion Criteria, Breast Cancer Patient Participants:\n\n* Females with a diagnosis of invasive non-metastatic breast cancer (stage I-IIIC)\n* Scheduled to begin a course of chemotherapy with Adriamycin and Cytoxan\n* Chemotherapy naïve\n* Able to speak and read English\n* 21 years or older\n* Give written informed consent\n\nExclusion Criteria, Breast Cancer Patient Participants:\n\n* Must not be currently hospitalized or have been hospitalized within the last year for a psychiatric illness\n* Must not be diagnosed with a neurodegenerative disease (e.g., Alzheimer's disease, Parkinson's disease)\n* Must not have any Central Nervous System disease (e.g., movement disorder, multiple sclerosis)\n* Subjects could have had a TIA (transient ischemic attack) or stroke in the past if the TIA or stroke was greater than 1 year ago and the subject does not have any remaining symptoms\n* Must not be scheduled to receive concurrent radiation treatment while receiving chemotherapy.\n* Must not be colorblind\n\nInclusion Criteria, Control Participants:\n\n* Must be female and within 5 years of the age of the subject receiving chemotherapy\n* Able to speak and read English\n* Give written informed consent\n* 21 years or older\n\nExclusion Criteria, Control Participants:\n\n* Must not be currently hospitalized or have been hospitalized within the last year for a psychiatric illness\n* Must not be diagnosed with a neurodegenerative disease (e.g. Alzheimer's disease, Parkinson's disease)\n* Must not have Central Nervous System disease (e.g., movement disorder, multiple sclerosis)\n* Subjects could have had a TIA (transient ischemic attack) or stroke in the past if the TIA or stroke was greater than 1 year ago and the subject does not have any remaining symptoms\n* Must not have been diagnosed with cancer or previously have received chemotherapy\n* Must not be colorblind\n\nFor optional sub-study: MR safety assessed via Rochester Center for Brain Imaging Magnetic Resonance (MR) Safety Screening Form to confirm eligibility to participate",{"count":487,"type":23},150,"Study is enrolling newly diagnosed breast cancer patients about to start chemotherapy and age-matched control participants. The investigator is trying to better understand the prevalence of cognitive difficulties in cancer patients receiving chemotherapy compared to the general population as well as what biological mechanisms may play a role in the development of these difficulties. Patients will be asked to complete six assessments over the course of approximately 5 months. Assessments 1,3, 4.5 and 5 include computerized and paper and pencil cognitive testing as well as blood draws. Assessments 2 and 4 only involve the collection of a blood sample. An optional sub study is offered after Assessment 1. It involves a research brain MRI at Assessment 4.5 and cognitive testing and another research brain MRI at Assessment 6.",[490,31],"Cancer Related Cognitive Difficulties","2026-04-22",{"date":493,"type":41},"2026-04-24",{"date":495,"type":41},"2017-02-20",{"date":497,"type":23},"2027-07-31",{"name":499,"class":48},"University of Rochester",{"id":501,"slug":502,"hasResults":12,"nctId":503,"briefTitle":504,"officialTitle":505,"acronym":506,"eligibilityCriteria":507,"healthyVolunteers":12,"sex":18,"minAge":83,"maxAge":508,"enrollmentInfo":509,"targetDuration":511,"studyType":62,"phases":4,"briefSummary":512,"conditions":513,"keywords":519,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":536,"lastUpdatePostDateStruct":537,"startDateStruct":539,"completionDateStruct":541,"leadSponsor":543,"locationsCount":135},"100631831","atusa-ultrasound-diagnostic-imaging-for-breast-lesions-evaluation-audible-100631831","NCT07505797","ATUSA Ultrasound Diagnostic Imaging for Breast Lesions Evaluation (AUDIBLE)","ATUSA Ultrasound Diagnostic Imaging for Breast Lesions Evaluation (AUDIBLE), a Case Collection Registry for 3D Breast Automated Ultrasound Using ATUSA System as Well as Other Breast Imaging Modalities.","AUDIBLE","Inclusion Criteria:\n\n1. Provide written informed consent through a signed and dated consent form.\n2. Demonstrate commitment to complete all study requirements and maintain availability for the full study duration.\n3. Be female, aged 18 to 94 years (inclusive).\n4. Have a recent BI-RADS® 4 or 5 classification confirmed through breast imaging and medical records.\n\nExclusion Criteria:\n\n1. Active skin lesions (open wounds or unhealed sores) on either breast.\n2. Implanted medical devices (pacemakers, defibrillators) or MRI incompatible materials that cannot be temporarily removed.\n3. Current pregnancy or breastfeeding status (self-reported).Documented hypersensitivity to silicone or gadolinium-based contrast agents.\n4. Previous bilateral mastectomy.\n5. Physical inability to maintain a supine position for 30 minutes.\n6. Breast anatomy incompatible with ATUSA device specifications.\n7. Recent (within 12 months) breast surgery or cancer treatment.\n8. Negative findings on diagnostic ultrasound examination within 30 days of Screening, but prior to initiating study required procedures.\n9. Any medical or psychological condition that, in the Principal Investigator's judgment, could affect study participation or data integrity.","94 Years",{"count":510,"type":23},800,"7 Days","AUDIBLE is a multi-site, clinical study conducted in the United States aimed at gathering data on 3D Automated Breast Ultrasound imaging using the iSono Health ATUSA system. The study focuses on female participants who have previously been identified with suspicious findings (classified as BIRADs 4 or 5) through standard-of-care diagnostic imaging methods (e.g., hand-held ultrasound, mammograms) and who have been referred for a biopsy. The goal is to create a comprehensive registry that includes multi-modality breast images alongside and biopsy results. The study will enroll up to 800 eligible female patients. In addition to imaging data, the study will collect information from the patient's medical records and biopsy outcomes.\n\nThe study aims to validate ATUSA's image quality, reproducibility, and correlation with histopathology and radiologist-assigned BI-RADS categories. Additionally, a subset of participants receiving neoadjuvant therapy will be followed longitudinally to evaluate ATUSA's potential for monitoring treatment response and volumetric changes in tumor burden.\n\nThis study supports the advancement of a patient-friendly, radiation-free, operator-independent ultrasound platform for real-time breast imaging.",[29,514,515,30,516,31,517,518],"Benign Breast Condition","Breast Fibroadenoma","Breast Disease","Breast Pain","Breast Cancer Invasive",[177,520,521,522,523,524,525,526,527,528,529,530,531,532,533,534,535],"breast lesions","dense breasts","invasive breast carcinoma","benign breast disease","ATUSA","Automated Breast Utrasound","ABUS","Ultrasound breast imaging","multimodality imaging","ultrasound","registry","image quality","AI","AI Model Training","medical device","iSono Health","2026-03-26",{"date":538,"type":41},"2026-04-01",{"date":540,"type":41},"2025-12-16",{"date":542,"type":23},"2026-12-31",{"name":544,"class":74},"iSono Health, Inc.",{"id":546,"slug":547,"hasResults":12,"nctId":548,"briefTitle":549,"officialTitle":550,"acronym":551,"eligibilityCriteria":552,"healthyVolunteers":12,"sex":18,"minAge":83,"maxAge":4,"enrollmentInfo":553,"targetDuration":4,"studyType":24,"phases":555,"briefSummary":556,"conditions":557,"keywords":558,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":560,"lastUpdatePostDateStruct":561,"startDateStruct":563,"completionDateStruct":565,"leadSponsor":567,"locationsCount":135},"100372720","xenografts-development-from-surgical-tumor-samples-of-patients-with-triple-negative-or-luminal-b-breast-cancer-100372720","NCT04133077","Xenografts Development From Surgical Tumor Samples of Patients With Triple Negative or Luminal B Breast Cancer","A Prospective Study of Xenografts Development From Samples Taken From Surgical Specimens of Patients With Triple Negative or Luminal B Breast Cancer","XenoBreast","Inclusion Criteria:\n\n* ECOG (Eastern Cooperative Oncology Group) performance status ≤ 2\n* Signature of the participation consent to the study,\n* Affiliation to a social security scheme\n* Major woman with:\n\n  * metastatic triple-negative (TN) breast cancer, histologically proven before treatment and high grade, receiving neoadjuvant chemotherapy and having, after treatment, a breast residue of at least 15 mm on the specimen. The mammary residue will measure at least 15 mm on the mammography performed at the end of neoadjuvant treatment\n  * metaplastic triple-negative (TN) breast cancer, histologically proven before treatment and high grade, treated by primary surgery with a tumor size of at least 15 mm on the specimen.\n  * an inflammatory TN breast cancer (T4d), histologically proven prior to treatment, receiving neoadjuvant chemotherapy and having, after treatment, a breast residue of at least 15 mm on the specimen. The mammary residue will measure at least 15 mm on the mammography performed at the end of the neoadjuvant treatment.\n  * non-metaplastic or inflammatory TN breast cancer, histologically proven prior to treatment, receiving neoadjuvant chemotherapy and having, after treatment, a mammary residue of at least 30 mm on the specimen. The mammary residue will measure at least 15 mm on the mammography performed at the end of the neoadjuvant treatment.\n  * Luminal B breast cancer (LB), histologically proven prior to treatment, receiving neoadjuvant chemotherapy and having, after treatment, a mammary residue of at least 30 mm on the specimen. The mammary residue will measure at least 15 mm on the mammography performed at the end of the neoadjuvant treatment.\n  * histologically proven metastatic TN or metastatic breast cancer with an operable metastasis whose residual size, after chemotherapy, is at least 10 mm on the specimen. Residual metastasis will be at least 15 mm on imaging.\n* Patients in a metastatic situation can be included regardless of the therapeutic line.\n\nExclusion Criteria:\n\n* Pregnant woman\n* Patient deprived of liberty by court or administrative decision\n* In neoadjuvant situation: no neoadjuvant treatment by radiotherapy or hormone therapy\n* Refusal to participate in the study",{"count":554,"type":23},85,[26],"Patient derived xenografts (PDX) from mammary tumors are usually made from metastatic tumors. Indeed, PDX from primitive mammary tumors or after neoadjuvant treatment are still rare. However, the realization of such PDX (from primitive mammary tumors or after neoadjuvant treatment) would make it possible to have a better knowledge of the tumor heterogeneity to the therapeutic response, to explore the models of tumor evolution during metastatic progression and also observe the mechanisms of tumor resistance in the case of non-metastatic tumors. It therefore seems necessary to develop PDX from primitive tumors in order to observe firstly the success rate of PDX; on the other hand, the drift of the initial heterogeneity, measured by comparison of the histomolecular profile of the tumors with that of the PDXs. It aims to develop xenografts from tumor samples from surgical specimens of patients with triple negative or luminal B breast cancer.",[31],[559],"PDX","2026-03-18",{"date":562,"type":41},"2026-03-19",{"date":564,"type":41},"2021-11-19",{"date":566,"type":23},"2030-08-31",{"name":568,"class":48},"Centre Jean Perrin",{"id":570,"slug":571,"hasResults":12,"nctId":572,"briefTitle":573,"officialTitle":574,"acronym":4,"eligibilityCriteria":575,"healthyVolunteers":12,"sex":18,"minAge":83,"maxAge":4,"enrollmentInfo":576,"targetDuration":4,"studyType":24,"phases":577,"briefSummary":578,"conditions":579,"keywords":581,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":585,"lastUpdatePostDateStruct":586,"startDateStruct":587,"completionDateStruct":589,"leadSponsor":590,"locationsCount":135},"100440843","phase-2-microbiome-and-association-with-implant-infections-100440843","NCT05020574","Microbiome and Association With Implant Infections","Microbiome and Association With Implant Infections: Investigating the Impact of Antibiotics on the Gut and Breast Microbiomes Post-mastectomy With Implant-based Breast Reconstruction","Inclusion Criteria:\n\n1. Patients must have histologically confirmed breast malignancy OR genetic predisposition to breast cancer.\n2. Age \\>= 18 years\n3. Scheduled to undergo mastectomy with the immediate placement of tissue expanders or implant placement\n4. Ability to understand a written informed consent document, and the willingness to sign it\n5. At least 4 weeks post-completion of chemotherapy or radiation therapy.\n\nExclusion Criteria:\n\n1. Any significant medical condition or laboratory abnormalities, which places the subject at unacceptable risk if he\u002Fshe were to participate in the study\n2. Pregnant or breastfeeding\n3. Patients who have taken antibiotics within 90 days of the consent date\n4. Patients who have taken probiotics within 90 days of the consent date\n5. Patients who have a documented or reported allergic reaction to the outlined antibiotics to be used in this study\n6. Male patients",{"count":228,"type":23},[117],"The most common tissue expander-related infections are from Staphylococcus and Pseudomonas species. In addition, from breast tissue microbiome studies, Staphylococcus and Pseudomonas show variable abundance across samples. The investigator hypothesizes that participants undergoing mastectomy with high initial abundance of Staphylococcus and\u002For Pseudomonas are more likely to develop subsequent tissue expander-related infections from these respective organisms.",[29,31,580],"Genetic Predisposition to Disease",[582,583,584,469,91],"Post-Surgical Antibiotics","Breast Implant Infections","Breast Microbiome","2026-03-16",{"date":560,"type":41},{"date":588,"type":41},"2021-09-28",{"date":542,"type":23},{"name":591,"class":48},"University of California, San Francisco",{"id":593,"slug":594,"hasResults":12,"nctId":595,"briefTitle":596,"officialTitle":597,"acronym":598,"eligibilityCriteria":599,"healthyVolunteers":12,"sex":18,"minAge":83,"maxAge":4,"enrollmentInfo":600,"targetDuration":602,"studyType":62,"phases":4,"briefSummary":603,"conditions":604,"keywords":605,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":609,"lastUpdatePostDateStruct":610,"startDateStruct":612,"completionDateStruct":614,"leadSponsor":616,"locationsCount":75},"100328905","gammapod-registry-and-quality-of-life-nomogram-100328905","NCT03562273","GammaPod Registry and Quality of Life Nomogram","Tumor Bed Boost Using a Breast Specific Radiosurgery Device, The GammaPodTM: Registry Study and Evaluation of Quality of Life With Development of Sizing Nomogram","GCC 1876","Inclusion Criteria:\n\n* The patient must sign consent for study participation.\n* The patient must be female and have a diagnosis of an invasive or non-invasive breast cancer that was treated surgically by a partial mastectomy.\n* The patient must be deemed an appropriate candidate for breast conserving therapy (i.e. not pregnant, never had radiation to the treated breast, breast size would allow adequate cosmesis after volume loss from partial mastectomy).\n* Patients with involved lymph nodes are candidates for the study.\n* Surgical margins are negative for invasive (no tumor on ink) or non-invasive breast cancer (2 mm negative margin).\n* The greatest dimension of the tumor is less than 4cm before surgery.\n* Multifocal disease is allowed if it was removed by a single lumpectomy resection and the patient remained a candidate for breast conservation.\n* Age 18 years and older.\n* Women of childbearing potential (pre-menopausal defined as having a menstrual period within the past 1 year) must have a negative serum pregnancy test or complete a pregnancy waiver form per institutional policy.\n* The surgical cavity is clearly visible on CT images. Of note, clips are not required but recommended.\n* The patient must weigh less than 150Kg (330lb), which is the limit of the imaging couch.\n* The patient must be less than 6'6\" in height.\n* The patient must feel comfortable in the prone position.\n* Diagnosis of prior contralateral breast cancer is allowed.\n* Diagnosis of synchronous bilateral cancers is allowed. In this case if bilateral boosts are required, a patient would not have both treatments on the same day.\n* Oncoplastic reduction surgery is allowed if the lumpectomy cavity can be clearly visualized.\n\nExclusion Criteria:\n\n* Patients with proven multi-centric carcinoma (tumors in different quadrants of the breast or tumor separated by at least 4 cm).\n* Prior radiation therapy to that breast or that hemi thorax.\n* Unable to fit into the immobilization breast cup with an adequate seal.\n* Male gender.\n* Patient cannot comfortably be set up in the prone position (i.e. physical disability)\n* Unable to fit into the breast immobilization device due to breast size or other anatomical reason.\n* Mastectomy is the surgery performed.\n* Patient has received prior radiotherapy to the involved breast.\n* Tumor bed is less than 3 mm from the skin surface.\n* Greater than 50% of the target volume is above the upper border of the table.\n* Patients with skin involvement, regardless of tumor size.\n* Patients with connective tissue disorders specifically systemic lupus erythematosis, scleroderma, or dermatomyositis.\n* Patients with psychiatric or addictive disorders that would preclude obtaining informed consent.\n* Patients who are pregnant or lactating due to potential exposure of the fetus to RT and unknown effects of RT to lactating females.\n* Patients with breast implants\u002Ftissue expanders or flap reconstruction.",{"count":601,"type":23},160,"1 Year","This study is a prospective, single arm study (registry) summarizing patient-level adverse-event and tumor outcomes as well as a number of feasibility and dosimetric characteristics of delivering a single-fraction boost with the GammaPod.",[31],[606,607,608],"Breast Nomogram","Breast Cancer Quality of Life","GammaPod Registry","2026-02-18",{"date":611,"type":41},"2026-02-20",{"date":613,"type":41},"2019-01-03",{"date":615,"type":23},"2030-12",{"name":617,"class":48},"University of Maryland, Baltimore",{"id":619,"slug":620,"hasResults":12,"nctId":621,"briefTitle":622,"officialTitle":623,"acronym":4,"eligibilityCriteria":624,"healthyVolunteers":12,"sex":18,"minAge":625,"maxAge":58,"enrollmentInfo":626,"targetDuration":4,"studyType":24,"phases":628,"briefSummary":629,"conditions":630,"keywords":631,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":636,"lastUpdatePostDateStruct":637,"startDateStruct":639,"completionDateStruct":641,"leadSponsor":642,"locationsCount":135},"100557971","cognitive-rehabilitation-following-breast-cancer-treatment-100557971","NCT06545045","Cognitive Rehabilitation Following Breast Cancer Treatment","Pilot Testing of Metacognitive Strategy Training to Address Cancer-related Cognitive Impairment in Breast Cancer","Inclusion Criteria:\n\n* self-reported CRCI (Global Rating of Cognition dysfunction as \"Moderately\" \"Strongly \"or \"Extremely\" AND a Cognitive Failures Questionnaire1 (CFQ) score \\>30)\n* completed treatment for active cancer diagnosis (invasive ductal or lobular BrCA Stages I, II, or III) at least 6 months but not greater than 3 years prior to participation\n* able to read, write, and speak English fluently\n* able to provide valid informed consent\n* have a life expectancy of greater than 6 months at time of enrollment\n* on stable doses (i.e., no changes in past 90 days) of medications that are known to impact cognitive function (i.e., anti-depressants)\n\nExclusion Criteria:\n\n* prior cancer diagnoses of other sites with evidence of active disease within the past year\n* active diagnoses of any acute or chronic brain-related neurological conditions that can alter normal brain anatomy or function (e.g., Parkinson's disease, dementia, cerebral infarcts) dementia symptoms as indicated by a score of \\\u003C23 on the Montreal Cognitive Assessment (MoCA)\n* severe depressive symptoms (Personal Health Questionnaire-9 (PHQ-9) score of ≥21)\n* history of severe traumatic brain injury, prolonged loss of consciousness (e.g., coma)\n* conditions contraindicated for MRI (e.g., electrical implants, pumps, claustrophobia)\n* blue-yellow colorblindness\n* pregnancy\n\nThe screening methods identified in parentheses next to appropriate inclusion\u002Fexclusion criteria will be used to verify appropriate selection of study participants.","20 Years",{"count":627,"type":23},50,[26],"The goal of this proposed project is to evaluate the feasibility and preliminary effect of metacognitive strategy training to improve activity performance, cognition, and quality of life in breast cancer survivors with cancer-related cognitive impairment (CRCI). The other goal of this proposed project is to examine the effects of CO-OP on resting (rsFC)- and task-state functional connectivity as compared to an inactive control group.",[31],[632,29,633,634,635],"Cancer","Cognition","Metacognition","Activities of daily living","2026-02-17",{"date":638,"type":41},"2026-02-19",{"date":640,"type":41},"2024-10-31",{"date":272,"type":23},{"name":643,"class":48},"University of Missouri-Columbia",{"id":645,"slug":646,"hasResults":12,"nctId":647,"briefTitle":648,"officialTitle":648,"acronym":649,"eligibilityCriteria":650,"healthyVolunteers":17,"sex":18,"minAge":198,"maxAge":4,"enrollmentInfo":651,"targetDuration":4,"studyType":24,"phases":653,"briefSummary":654,"conditions":655,"keywords":656,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":660,"lastUpdatePostDateStruct":661,"startDateStruct":663,"completionDateStruct":665,"leadSponsor":667,"locationsCount":669},"100611556","conformal-ablative-radiotherapy-in-older-women-carmen-with-breast-cancer-undergoing-non-operative-management-100611556","NCT07242118","Conformal Ablative Radiotherapy in Older Women (CARMEN) With Breast Cancer Undergoing Non-Operative Management","CARMEN","Inclusion Criteria:\n\n* Willing and able to provide written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.\n* Women greater than or equal to age 65 years\n* Diagnosis of invasive carcinoma of breast undergoing non-operative management\n* Previously untreated OR previously treated with primary ET or chemotherapy, with either stable or progressive localized disease.\n* Tumor measuring ≤5 cm (cT1-T2) and clinically node negative\n* Diagnostic biopsy ER-positive (greater than or equal to 10% ER by immunohistochemistry staining)\n* Diagnostic biopsy HER2-negative according to ASCO\u002FCAP guidelines (0 or 1+ following IHC staining or proven negative by in-situ hybridization)\n* Suitable for SABR as deemed by the treating radiation oncologist\n* Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Enrollment in another clinical trial is allowed if there would be no interference with interventions on this trial\n\nExclusion Criteria:\n\n* Active treatment with systemic chemotherapy for breast cancer. Subjects will need to stop any breast cancer chemotherapy agent before enrollment to be included study.\n* Multicentric tumor.\n* Clinical or imaging evidence of distant metastases.\n* Prior ipsilateral breast or thoracic radiation.\n* Autoimmune conditions with associated radiation risks.",{"count":652,"type":23},18,[26],"This phase II study evaluates SABR as non-operative treatment for women aged 65+ with ER-positive, HER2-negative breast cancer ≤5 cm and no lymph node involvement. Eligible patients, including those previously on endocrine therapy, receive 5 SABR treatments, followed by monitoring of quality of life and assessment of treatment-related toxicity.",[31],[657,658,659],"Geriatric","ER-positive","HER2-negative","2026-02-06",{"date":662,"type":41},"2026-02-10",{"date":664,"type":41},"2025-11-04",{"date":666,"type":23},"2027-10",{"name":668,"class":48},"University of Kansas Medical Center",2,{"id":671,"slug":672,"hasResults":12,"nctId":673,"briefTitle":674,"officialTitle":675,"acronym":676,"eligibilityCriteria":677,"healthyVolunteers":12,"sex":18,"minAge":83,"maxAge":4,"enrollmentInfo":678,"targetDuration":4,"studyType":24,"phases":680,"briefSummary":681,"conditions":682,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":683,"lastUpdatePostDateStruct":684,"startDateStruct":685,"completionDateStruct":687,"leadSponsor":689,"locationsCount":135},"100523788","breast-cancer-resiliency-through-exercise-program-b-rep-100523788","NCT06100263","Breast Cancer Resiliency Through Exercise Program (B-REP)","Breast Cancer Resiliency Through Exercise Program (B-REP): Pilot Study","B-REP","Inclusion Criteria:\n\nWomen will be eligible if they meet the following criteria:\n\n* self-identify as Black or African American or Afro-Latina\u002Fe;\n* are ≥18 years old;\n* have a confirmed diagnosis of breast cancer, Stage I to IIIA;\n* have completed primary active treatment (i.e., surgery, chemotherapy, and radiation) within 5 years prior to study start where concomitant hormonal therapy is acceptable;\n* are not meeting current cancer-specific resistance exercise guidelines of ≥ 2 times per week; and\n* are able to speak and understand English.\n\nExclusion Criteria:\n\n* metastatic disease;\n* medical reason that precludes them from increasing current exercise levels;\n* planned elective surgery during study period;\n* pregnant or plans to become pregnant during the study period;\n* plans to move out of United States during the study period; (the rationale for this exclusion is that it will be difficult to conduct the in-person assessments if a participant leaves the United States);\n* current enrollment in another exercise trial; and\u002For\n* inability to pass exercise pre-screening or receive physician consent to increase current physical activity levels.",{"count":679,"type":23},75,[26],"The study will use a cross-sectional study design with a follow-up 2-arm randomized controlled trial with that has assessments at baseline, post-intervention (i.e., Week 12), and 3-months post-intervention (i.e., Week 24). The 2 arms are the 12-week intervention and waitlist control among 30 Black breast cancer survivors",[31],"2026-02-05",{"date":662,"type":41},{"date":686,"type":41},"2024-05-28",{"date":688,"type":23},"2026-12",{"name":690,"class":48},"University of Michigan Rogel Cancer Center"]